PITTSBURGH, Pa. (Sept. 17, 2018) — A new, non-pharmaceutical treatment, Freespira, and non-invasive diagnostic technology, Heartflow FFRct (fractional flow reserve), were added to Highmark’s medical policy in 2018 following positive results from a program that fast-tracks medical innovations to the marketplace.
Freespira, an in-home digital therapeutic device for panic disorder and panic attacks occurring with other anxiety conditions, was added to Highmark’s medical policy in May 2018 and now covers the treatment option for members.
TechCrunch (Meri Beckwith) — It would be hard to argue that digital products have a net-positive impact on our health. Most are designed to provide the same dopamine hit as a slot machine. We all know someone who wasted their youth playing games that were designed to be all-consuming, with the World Health Organization recently going so far as to categorize video game addiction as a mental health disorder.
STAT News (Rebecca Robbins Adam Feuerstein) — One of the hottest fields in health care investing is digital health. Companies in the space collectively raised $3.4 billion in venture capital in the first half of this year, spread across 193 deals, according to a count from the venture firm Rock Health. If that pace continues, the sector will set a new record this year — both in terms of number of deals and VC money invested overall.
This pilot study developed and evaluated the feasibility, usability, and perceived satisfaction with an end-user mobile medical application and provider web portal. The two interfaces allowed for remote monitoring, provided daily guidance in the management of hypertension and diarrhea, and allowed for rapid management of adverse events during a clinical trial of olaparib and cediranib.
A study presented Monday at the American Diabetes Association (ADA) Scientific Sessions found that one-third of those who initially screened positive for prediabetes or diabetes were able to bring their blood sugar down to normal levels after taking part in a workforce-based intervention. The study by Quest Diagnostics, which involved a collaboration with the digital health provider Omada Health, shows promise for employer-based wellness programs that involve a 2-step process: screening for those at risk, and then offering an evidence-based program of lifestyle change and support for those whose health risks are revealed during screening. […]
WellDoc®, a leading digital health company revolutionizing chronic disease management to help transform lives through the use of its digital therapeutics, today announced results from an innovative economic analysis that demonstrated the potential for significant healthcare cost savings with the use of BlueStar®. BlueStar is powered by WellDoc and is a 510K-cleared digital therapeutic designed to coach adults with type 2 diabetes. […]
MobiHealthNews (Laura Lovett) — A drug no longer needs to be a tangible object, according to panelist at the BIO 2018 convention in Boston. The way the pharma industry looks at medication is evolving and may be including new tech-focused treatments, such as digital therapeutics. “If you think about the trajectory of medicine what is a drug these days: is it a pill, is it an injection, is it infusion, is it gene therapy? We’ve created some artificial constructs in the industry,” Jeremy Sohn, vice president and global head of digital business development and licensing at Novartis, said at a panel discussion on Wednesday. “The thing that is always constant, as the FDA will tell us, is it is about data-driven processes that allow us to demonstrate efficacy and truth.” […]
WASHINGTON, June 4, 2018 /PRNewswire-USNewswire/ – The Digital Therapeutics Alliance (DTA) and USP announced a collaboration to explore the development of appropriate standards and guidelines for digital therapeutics at a roundtable discussion co-hosted by the two organizations today at USP headquarters in Rockville, MD.
“Innovative digital therapies have the potential to dramatically affect the way healthcare is delivered,” said Megan Coder, PharmD, DTA executive director. “Without quality as a priority in delivering these therapies, patients face a challenging landscape in determining which products to trust when it comes to technology in their health care. Working with USP enables us to promote the development of quality standards that allow patients and clinicians to have even greater confidence using digital therapeutics.”
Digital therapeutics deliver medical interventions via clinically-validated technologies to prevent, manage, and treat medical conditions and may be used standalone or in conjunction with therapeutic pathways to optimize patient care and health outcomes. From device and medication sensors to patient-focused applications and software, digital therapeutics create opportunities to strengthen current clinical interventions and disease management options for patients with diabetes, asthma, heart disease, substance abuse, pain, sleep disturbances, and other conditions.
“DTA’s commitment to ensuring quality aligns well with USP’s nearly 200-year mission of ensuring quality through standards,” explained USP CEO Ronald Piervincenzi, Ph.D. “Digital therapeutics represent an emerging industry, and this collaboration is an opportunity for USP to demonstrate how public standards can help ensure quality for patients even on the cutting edge of technology.”
The roundtable included stakeholders who shared their perspectives on the future of digital therapeutics and the collaboration with USP, as well as their concerns with quality in this area.
“Digital therapeutics offer new treatment options and completely change our definition of medicine,” said Eddie Martucci, Ph.D., Akili Interactive’s co-founder and CEO. “We envision a future where medical treatments continue to be quality-focused and effective but can also be highly engaging and interactive. Working with USP, we can deliver on both the promise of this field and the assurance of quality we’ve come to expect in medicine.”
“Mapping between the rigor of USP’s approach and the digital therapeutics landscape is a key opportunity for all of us,” offered Anand Iyer, Ph.D., MBA, WellDoc’s Chief Strategy Officer. “We have to find ways to match the accelerated evolution of the digital therapeutics industry with the commitment to quality standards at USP to capture the future of technology in health care each of us desires.”
This collaboration will explore ways to safeguard product quality and integrity for digital therapeutics, with input from relevant stakeholders. If areas of need are identified, any development of standards or guidelines will follow USP’s usual, rigorous public processes.
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About USP
USP is an independent non-profit organization that collaborates with the world’s top health and science experts to develop high-quality standards that set the bar for manufacturing and distributing safe and effective medicines, supplements and food around the globe. Two billion people world-wide have access to quality medicines, dietary supplements and food as a result of USP’s standards, advocacy and education.
About DTA
The Digital Therapeutics Alliance is a global nonprofit trade association with the mission of broadening the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. To learn more please visit: www.dtxalliance.org.
Voluntis, a company specialized in digital therapeutics, and WellDyneRx, a full-service, independent pharmacy benefit manager (PBM), announced today that Voluntis’ Insulia® will be incorporated into the recently-launched WellManaged-Diabetes program. This innovative, patient-centered program uses a high touch model often seen in traditional specialty pharmacy for high cost medications and expands its application to better serve WellDyneRx members with diabetes.
Arlington, VA — May 8, 2018 — The Digital Therapeutics Alliance welcomes nine companies to membership: Bayer, Big Health, Cognoa, Kaia Health, Merck, Omada Health, Otsuka America Pharmaceutical, Inc., Pear Therapeutics, and Sanofi.
“Digital medicine has the potential to safely and effectively help millions of people suffering from chronic and mental health conditions. We are proud to hold digital therapeutics to the same standards of clinical evidence as traditional medicine,” said Peter Hames, Co-Founder, CEO of Big Health.
DTA launched in October 2017 through a collaboration of four digital therapeutics companies: Akili Interactive, Propeller Health, Voluntis, and WellDoc. “DTA is committed to convening industry leaders sharing a passion for crafting a strong future for the integration of tested, trustworthy digital solutions in healthcare,” said Pierre Leurent, CEO of Voluntis and DTA Board of Directors Chair.
“Digital therapeutics is a shining light in the crowded digital health landscape. Each DTA member has used clinical validation and evidence to provide data-driven treatment options and we look forward to working with the Alliance to advance this evidence-based approach,” says Eugene Borukhovich, Global Head, Digital Health at Bayer.
In its first year, DTA is committed to engaging with patients, providers, payers, and regulators to define and develop meaningful resources to guide and scale this quickly evolving industry.
“Patients, clinicians, and insurers are looking for effective solutions to prevent, manage, and treat chronic disease,” said Sean Duffy, CEO, Omada Health. “Digital therapeutics deliver reliable, meaningful clinical results that empower patients. This is important work.”
“We are pleased to work with the Alliance on the introduction of prescription digital therapeutics,” said Corey McCann, President and CEO of Pear Therapeutics. “DTA has a critical role ensuring digital therapeutics are clinically-validated, built according to Good Manufacturing Practices, rooted in Good Clinical Practices, and evaluated thoroughly by regulatory bodies to verify these products are safe and effective. Patients and providers deserve nothing less than the same standards of any other therapeutic.”
About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. To learn more please visit: www.dtxalliance.org.